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Cardiovascular Drugs and Therapy Jun 2022The optimal dosing strategy of four-factor prothrombin complex concentrate (4F-PCC) for vitamin K antagonists (VKAs) reversal is unknown. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The optimal dosing strategy of four-factor prothrombin complex concentrate (4F-PCC) for vitamin K antagonists (VKAs) reversal is unknown.
METHODS
We conducted systematic search on the PubMed, SCOPUS, and Embase databases from inception to December 2020 for clinical studies that compared the fixed-dose versus variable-dose of 4-PCC for VKAs reversal with at least one reported clinical outcome. The treatment effects were expressed as relative ratios (RR) with 95% confidence intervals (CIs) and pooled by a random-effects model.
RESULTS
Ten studies, including 988 patients, were included. Fixed-dose 4-PCC was associated with lower rate of mortality (RR= 0.65, 95% CI 0.47 to 0.9, p= 0.009), comparable rate of thromboembolic event (TEE) (RR= 1.10, 95%CI 0.44 to 2.80, p= 0.826), and lower goal INR reached (RR= 0.87, 95%CI 0.78 to 0.96, p= 0.007). Less 4-PCC cumulative dose, shorter duration of order-to-needle time, similar hospital length of stay, the comparable time required for INR reversal, higher post-4-PCC INR, and a higher need for additional dose were observed in fixed-dose.
CONCLUSIONS
The use of a fixed-dose of 4-PCC may be considered an effective and safe dosing strategy for VKAs reversal in various clinical situations. However, further well-designed, controlled studies should be conducted focusing on clinical outcomes to determine the optimal dose of 4-PCC for VKAs reversal.
Topics: Anticoagulants; Fibrinolytic Agents; Humans; International Normalized Ratio; Retrospective Studies; Thromboembolism; Vitamin K
PubMed: 33864534
DOI: 10.1007/s10557-021-07192-0 -
Journal of Perinatal Medicine Feb 2021To compare the safety and efficacy between high dose and low dose oxytocin administration for labor augmentation. (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVES
To compare the safety and efficacy between high dose and low dose oxytocin administration for labor augmentation.
METHODS
We searched for the available studies during March 2020 in PubMed, Cochrane Library, Scopus, and ISI Web of science. All randomized clinical trials (RCTs) that assessed safety and efficacy of high dose vs. low dose oxytocin for labor augmentation were considered. The extracted data were entered into RevMan software. Dichotomous and continuous data were pooled as odds ratio (OR) and mean difference (MD) respectively, with the corresponding 95% confidence intervals (CI). Our main outcomes were cesarean delivery rate, spontaneous vaginal delivery rate, uterine hyperstimulation and tachysystole, and labor duration from oxytocin infusion.
RESULTS
Eight RCTs with 3,154 patients were included. High dose oxytocin did not reduce cesarean delivery rate compared to low dose oxytocin (OR=0.76, 95% CI [0.52, 1.10], p=0.15). After solving the reported heterogeneity, high dose oxytocin did not increase the rate of spontaneous vaginal deliveries vs. low dose oxytocin (OR=1.06, 95% CI [0.84, 1.32], p=0.64). Low dose oxytocin was linked to a significant decline in uterine hyperstimulation and tachysystole (p>0.001). A reduction in labor duration was found in high dose oxytocin group over low oxytocin regimen (MD=-1.02 h, 95% CI [-1.77, -0.27], p=0.008).
CONCLUSIONS
We found no advantages for high dose oxytocin over low dose oxytocin in labor augmentation except in reducing labor duration. Low dose oxytocin is safer as it decreases the incidence of uterine hyperstimulation and tachysystole. More trials are needed to confirm our findings.
Topics: Delivery, Obstetric; Female; Humans; Infant, Newborn; Labor, Obstetric; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 32950965
DOI: 10.1515/jpm-2020-0042 -
JAMA Network Open Feb 2021Low-dose intradermal influenza vaccines could be a suitable alternative to full intramuscular dose during vaccine shortages. (Comparative Study)
Comparative Study Meta-Analysis
IMPORTANCE
Low-dose intradermal influenza vaccines could be a suitable alternative to full intramuscular dose during vaccine shortages.
OBJECTIVE
To compare the immunogenicity and safety of the influenza vaccine at reduced or full intradermal doses with full intramuscular doses to inform policy design in the event of vaccine shortages.
DATA SOURCES
MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched for studies published from 2010 until June 5, 2020.
STUDY SELECTION
All comparative studies across all ages assessing the immunogenicity or safety of intradermal and intramuscular influenza vaccinations were included.
DATA EXTRACTION AND SYNTHESIS
Data were extracted by a single reviewer and verified by a second reviewer. Discrepancies between reviewers were resolved through consensus. Random-effects meta-analysis was conducted.
MAIN OUTCOMES AND MEASURES
Primary outcomes included geometric mean titer, seroconversion, seroprotection, and adverse events.
RESULTS
A total of 30 relevant studies were included; 29 studies were randomized clinical trials with 13 759 total participants, and 1 study was a cohort study of 164 021 participants. There was no statistically significant difference in seroconversion rates between the 3-µg, 6-µg, 7.5-µg, and 9-µg intradermal vaccine doses and the 15-µg intramuscular vaccine dose for each of the H1N1, H3N2, and B strains, but rates were significantly higher with the 15-µg intradermal dose compared with the 15-µg intramuscular dose for the H1N1 strain (rate ratio [RR], 1.10; 95% CI, 1.01-1.20) and B strain (RR, 1.40; 95% CI, 1.13-1.73). Seroprotection rates for the 9-µg and 15-µg intradermal doses did not vary significantly compared with the 15-µg intramuscular dose for all the 3 strains, except for the 15-µg intradermal dose for the H1N1 strain, for which rates were significantly higher (RR, 1.05; 95% CI, 1.01-1.09). Local adverse events were significantly higher with intradermal doses than with the 15-µg intramuscular dose, particularly erythema (3-µg dose: RR, 9.62; 95% CI, 1.07-86.56; 6-µg dose: RR, 23.79; 95% CI, 14.42-39.23; 9-µg dose: RR, 4.56; 95% CI, 3.05-6.82; 15-µg dose: RR, 3.68; 95% CI, 3.19-4.25) and swelling (3-µg dose: RR, 20.16; 95% CI, 4.68-86.82; 9-µg dose: RR, 5.23; 95% CI, 3.58-7.62; 15-µg dose: RR, 3.47 ; 95% CI, 2.21-5.45). Fever and chills were significantly more common with the 9-µg intradermal dose than the 15-µg intramuscular dose (fever: RR, 1.36; 95% CI, 1.03-1.80; chills: RR, 1.24; 95% CI, 1.03-1.50) while all other systemic adverse events were not statistically significant for all other doses.
CONCLUSIONS AND RELEVANCE
These findings suggest that reduced-dose intradermal influenza vaccination could be a reasonable alternative to standard dose intramuscular vaccination.
Topics: Antibodies, Viral; Chills; Dose-Response Relationship, Immunologic; Fever; Hemagglutination Inhibition Tests; Humans; Immunogenicity, Vaccine; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Influenza B virus; Influenza Vaccines; Influenza, Human; Injection Site Reaction; Injections, Intradermal; Injections, Intramuscular; Seroconversion
PubMed: 33560425
DOI: 10.1001/jamanetworkopen.2020.35693 -
Brachytherapy 2021The purpose of this guideline is to present evidence-based consensus recommendations for low dose rate (LDR) permanent seed brachytherapy for the primary treatment of...
PURPOSE
The purpose of this guideline is to present evidence-based consensus recommendations for low dose rate (LDR) permanent seed brachytherapy for the primary treatment of prostate cancer.
METHODS AND MATERIALS
The American Brachytherapy Society convened a task force for addressing key questions concerning ultrasound-based LDR prostate brachytherapy for the primary treatment of prostate cancer. A comprehensive literature search was conducted to identify prospective and multi-institutional retrospective studies involving LDR brachytherapy as monotherapy or boost in combination with external beam radiation therapy with or without adjuvant androgen deprivation therapy. Outcomes included disease control, toxicity, and quality of life.
RESULTS
LDR prostate brachytherapy monotherapy is an appropriate treatment option for low risk and favorable intermediate risk disease. LDR brachytherapy boost in combination with external beam radiation therapy is appropriate for unfavorable intermediate risk and high-risk disease. Androgen deprivation therapy is recommended in unfavorable intermediate risk and high-risk disease. Acceptable radionuclides for LDR brachytherapy include iodine-125, palladium-103, and cesium-131. Although brachytherapy monotherapy is associated with increased urinary obstructive and irritative symptoms that peak within the first 3 months after treatment, the median time toward symptom resolution is approximately 1 year for iodine-125 and 6 months for palladium-103. Such symptoms can be mitigated with short-term use of alpha blockers. Combination therapy is associated with worse urinary, bowel, and sexual symptoms than monotherapy. A prostate specific antigen <= 0.2 ng/mL at 4 years after LDR brachytherapy may be considered a biochemical definition of cure.
CONCLUSIONS
LDR brachytherapy is a convenient, effective, and well-tolerated treatment for prostate cancer.
Topics: Androgen Antagonists; Brachytherapy; Consensus; Humans; Male; Prospective Studies; Prostate-Specific Antigen; Prostatic Neoplasms; Quality of Life; Retrospective Studies
PubMed: 34509378
DOI: 10.1016/j.brachy.2021.07.006 -
The British Journal of Radiology Jul 2018This study aimed (1) to perform a systematic review on scanning parameters and contrast medium (CM) reduction methods used in prospectively electrocardiography... (Review)
Review
OBJECTIVE
This study aimed (1) to perform a systematic review on scanning parameters and contrast medium (CM) reduction methods used in prospectively electrocardiography (ECG-triggered low tube voltage coronary CT angiography (CCTA), (2) to compare the achievable dose reduction and image quality and (3) to propose appropriate scanning techniques and CM administration methods.
METHODS
A systematic search was performed in PubMed, the Cochrane library, CINAHL, Web of Science, ScienceDirect and Scopus, where 20 studies were selected for analysis of scanning parameters and CM reduction methods.
RESULTS
The mean effective dose (H) ranged from 0.31 to 2.75 mSv at 80 kVp, 0.69 to 6.29 mSv at 100 kVp and 1.53 to 10.7 mSv at 120 kVp. Radiation dose reductions of 38 to 83% at 80 kVp and 3 to 80% at 100 kVp could be achieved with preserved image quality. Similar vessel contrast enhancement to 120 kVp could be obtained by applying iodine delivery rate (IDR) of 1.35 to 1.45 g s with total iodine dose (TID) of between 10.9 and 16.2 g at 80 kVp and IDR of 1.08 to 1.70 g s with TID of between 18.9 and 20.9 g at 100 kVp.
CONCLUSION
This systematic review found that radiation doses could be reduced to a rate of 38 to 83% at 80 kVp, and 3 to 80% at 100 kVp without compromising the image quality. Advances in knowledge: The suggested appropriate scanning parameters and CM reduction methods can be used to help users in achieving diagnostic image quality with reduced radiation dose.
Topics: Computed Tomography Angiography; Coronary Angiography; Electrocardiography; Humans; Radiation Dosage
PubMed: 29493261
DOI: 10.1259/bjr.20170874 -
Clinical Nephrology May 2018To seek an optimized immunotherapy which can preserve renal function while maintaining low acute rejection rates, we conducted a systematic review and meta-analysis of... (Meta-Analysis)
Meta-Analysis Review
Efficacy and safety of everolimus plus low-dose calcineurin inhibitor vs. mycophenolate mofetil plus standard-dose calcineurin inhibitor in renal transplant recipients: A systematic review and meta-analysis .
BACKGROUND
To seek an optimized immunotherapy which can preserve renal function while maintaining low acute rejection rates, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of everolimus (EVR) plus low-dose calcineurin inhibitor (CNI) vs. mycophenolate mofetil (MMF) plus standard-dose CNI regimen after kidney transplantation (KT).
MATERIALS AND METHODS
We searched for RCTs comparing the outcomes of EVR plus low-dose CNI and MMF plus standard-dose CNI regimen after KT and identified eligible RCTs according to strict inclusion and exclusion criteria. Two authors independently assessed the quality of included studies and performed a meta-analysis using RevMan5.3.
RESULTS
Eleven RCTs with 850 renal transplant recipients were included. This meta-analysis showed that EVR plus low-dose CNI regimen was associated with comparable renal function (standardized mean difference (SMD) 0.16, 95% CI (-0.03, 0.35), p = 0.09) and a similar rate of acute rejection (risk ratio (RR) 1.16, 95% CI (0.96, 1.42), p = 0.13), graft loss (RR 0.89, 95% CI (0.63, 1.24), p = 0.49) and mortality (RR 1.19, 95% CI (0.69, 2.08), p = 0.53) compared to MMF plus standard-dose CNI regimen. In addition, EVR plus low-dose CNI regimen could reduce the rate of cytomegalovirus and infection, whereas a lower rate of other adverse events were noted in MMF plus standard-dose CNI regimen.
CONCLUSION
EVR plus low-dose CNI regimen was similar in efficacy and safety to MMF plus standard-dose CNI regimen after KT. However, this should be confirmed by further studies. .
Topics: Calcineurin Inhibitors; Everolimus; Humans; Kidney Transplantation; Mycophenolic Acid
PubMed: 29292693
DOI: 10.5414/CN109287 -
Journal of Neonatal-perinatal Medicine 2022Several small randomized controlled trials (RCTs) and observational studies have compared high (15-20/7.5-10/7.5-10 mg/kg/dose) versus standard dose... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several small randomized controlled trials (RCTs) and observational studies have compared high (15-20/7.5-10/7.5-10 mg/kg/dose) versus standard dose (10/5/5 mg/kg/dose) ibuprofen for patent ductus arteriosus (PDA) closure, with limited evidence on efficacy and safety.
OBJECTIVE
To systematically review and meta-analyze studies of high versus standard dose ibuprofen for the closure of PDA in preterm infants.
METHODS
Databases were searched for RCTs and observational studies assessing high compared to standard dose of ibuprofen for PDA closure for preterm infants until August 2021. The primary outcome was failure of PDA closure after the first course of ibuprofen. The secondary outcomes were the failure of PDA closure after a second course of ibuprofen, rates of PDA ligation, all-cause mortality prior to hospital discharge, bronchopulmonary dysplasia, necrotizing enterocolitis, bleeding disorders, oliguria, and serum creatinine after treatment.
RESULTS
There were 6 studies with 369 patients (3 RCT, N = 190; 3 observational studies, N = 179). Compared to standard dose, high dose ibuprofen did not significantly decrease the failure rate of PDA closure in preterm infants after the first course (Relative risk (RR) 0.74, 95% confidence interval (CI) 0.53 -1.03, 6 studies, N = 369). High dose ibuprofen significantly decreased the rates of PDA ligation compared to standard dose (RR 0.33, 95% CI 0.16 -0.70, 5 studies, N = 309).
INTERPRETATION
Based on low-grade evidence, high dose ibuprofen may more effectively reduce rates of PDA ligation compared to standard dose with no increase in adverse effects, neonatal morbidities and mortality.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature
PubMed: 35404294
DOI: 10.3233/NPM-210968 -
Tumour Biology : the Journal of the... Oct 2014The objective of this study is to evaluate whether high-dose chemotherapy is more efficacious than standard-dose chemotherapy in the treatment of primary... (Meta-Analysis)
Meta-Analysis Review
The objective of this study is to evaluate whether high-dose chemotherapy is more efficacious than standard-dose chemotherapy in the treatment of primary well-differentiated osteosarcoma. The Cochrane systematic evaluation method was adopted. A database search was conducted in MEDLINE, Embase, OVID, the Cochrane Central Register of Controlled Trials database and the Chinese Biomedical Literature CD-ROM Database. The quality of the included studies was jointly evaluated by two reviewers, and homogeneous studies were included for meta-analysis. A total of five studies were included in this meta-analysis, with 1,415 subjects with primary, nonmetastatic, well-differentiated osteosarcoma in the limbs. No statistically significant differences were found between the high-dose chemotherapy group and the low-dose group in 5-year event-free survival [RR 1.04, 95 %CI (0.95, 1.13)], 5-year overall survival [RR 1.02, 95 %CI (0.95, 1.10)], local recurrence rate [RR 0.90, 95 %CI (0.59, 1.39)], proportion of subjects with good histological response [RR 0.93, 95 %CI (0.81, 1.07)], or limb salvage rate [RR 0.97, 95 %CI (0.92, 1.02)]. A statistically significant difference was observed in the 5-year event-free survival between the subjects with good histological response to preoperative chemotherapy and the subjects with poor histological response [RR 1.55, 95 %CI (1.19, 2.00), P < 0.001]. High-dose chemotherapy did not show superior efficacy to low-dose chemotherapy in the treatment of primary well-differentiated osteosarcoma. Further high-quality randomized controlled trials are needed to provide additional reliable evidence for our observation.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Cell Differentiation; Humans; Osteosarcoma; Randomized Controlled Trials as Topic
PubMed: 25053592
DOI: 10.1007/s13277-014-2253-x -
Asian Journal of Anesthesiology Mar 2021Dexmedetomidine is a highly selective α2-adrenoceptor agonist, which is off-labelled use for pediatric sedation. However, the hemodynamic responses of dexmedetomidine... (Meta-Analysis)
Meta-Analysis Review
Dexmedetomidine is a highly selective α2-adrenoceptor agonist, which is off-labelled use for pediatric sedation. However, the hemodynamic responses of dexmedetomidine remain unclear in the pediatric population. The primary objectives of this systematic review and meta-analysis were to examine the hemodynamic effects of high-dose and low-dose dexmedetomidine in pediatric patients undergoing surgery. EMBASE, MEDLINE, and CENTRAL were systematically searched from its inception until April 2019. All randomized clinical trials comparing high-dose (> 0.5 mcg/kg) and low-dose (≤ 0.5 mcg/ kg) dexmedetomidine in pediatric surgical patients were included, regardless of the types of surgeries. Observational studies, case series, and case reports were excluded. Four trials (n = 473) were included in this review. Our review demonstrated that high-dose dexmedetomidine was associated with lower heart rate than low-dose dexmedetomidine after intravenous bolus of dexmedetomidine (studies, 3; n = 274; mean difference [MD], -5 [-6 to -4]; P < 0.0001) and during surgical stimulant (studies, 2; n = 153; MD, -11 [-13 to -9]; P < 0.0001). In comparison to the low-dose dexmedetomidine, high-dose dexmedetomidine was also associated with a significant longer recovery time (studies, 3; n = 257; MD, 5.90 [1.56 to 10.23]; P = 0.008) but a lower incidence of emergence agitation (studies, 2; n = 153; odds ratio, 0.17 [0.03 to 0.95]; P = 0.040). In this meta-analysis, low-dose dexmedetomidine demonstrated better hemodynamic stability with shorter recovery time than high-dose dexmedetomidine. However, these findings need to be interpreted with caution due to limited published studies, a small sample size, and a high degree of heterogeneity.
Topics: Anesthesia, General; Child; Dexmedetomidine; Emergence Delirium; Hemodynamics; Humans; Randomized Controlled Trials as Topic
PubMed: 33504143
DOI: 10.6859/aja.202103_59(1).0002 -
BMJ Open Aug 2017To evaluate the optimal dose of succinylcholine for laryngeal mask airway (LMA) insertion and all related morbidities. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To evaluate the optimal dose of succinylcholine for laryngeal mask airway (LMA) insertion and all related morbidities.
DESIGN
Systematic review, meta-analysis and metaregression of randomised controlled trials (RCTs).
DATA SOURCE AND STUDY ELIGIBILITY CRITERIA
A comprehensive search of RCTs in the PubMed, Embase, the Cochrane Library and the ClinicalTrials.gov registry up to July 2016 and articles that evaluated the use of succinylcholine chloride for LMA insertion were included in the analyses. The relative risk (RR) and the corresponding 95% CIs were determined.
INTERVENTION
Succinylcholine as the coinduction agent and the doses were divided into mini (≤0.3 mg/kg) and low (0.3-1.0 mg/kg) doses for dose-dependent effect analyses.
PRIMARY AND SECONDARY OUTCOMES
The primary outcome was the first-attempt LMA insertion failure rate. Secondary outcomes included all related adverse events.
RESULTS
Data from 10 RCTs comprising 625 participants showed that succinylcholine reduced the first-attempt LMA insertion failure rate (RR, 0.22; 95% CI 0.12 to 0.43), coughing and gagging (RR, 0.26; 95% CI 0.15 to 0.45) and laryngospasm (RR, 0.14; 95% CI 0.05 to 0.39). The use of succinylcholine did not result in a significant increase of postoperative myalgia (RR, 2.58; 95% CI 0.79 to 8.44) and did not reduce the risk of postoperative sore throat (RR, 0.76; 95% CI 0.55 to 1.03). Subgroup analysis further showed that low-dose succinylcholine reduced the LMA insertion failure rate and its related coughing and gagging when compared with mini dose.
CONCLUSION
The use of succinylcholine compared with none can facilitate LMA insertion and reduce insertion-related reflexes without significant postoperative myalgia. However, additional prospective studies with a larger sample size are required to fully evaluate the dose-dependent effect and complications of succinylcholine for LMA insertion.
Topics: Cough; Dose-Response Relationship, Drug; Gagging; Humans; Intubation, Intratracheal; Laryngeal Masks; Neuromuscular Depolarizing Agents; Pain, Postoperative; Pharyngitis; Randomized Controlled Trials as Topic; Succinylcholine; Treatment Outcome
PubMed: 28780538
DOI: 10.1136/bmjopen-2016-014274